Non-Drug Treatments for Anxiety Disorder
(RESYNC-BH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores non-drug treatments to help manage symptoms of anxiety, depression, trauma, sleep issues, and more. Researchers aim to determine if personalized approaches, such as brain stimulation, sensory experiences, and specialized therapy, improve mental health and daily life. Participants will try different combinations, including therapy with techniques like regulated breathing or brain stimulation, to identify the most effective methods. Individuals experiencing significant anxiety, depression, or related symptoms who are stable on medications might be suitable candidates. The goal is to determine if these treatments lead to measurable improvements in both brain and body signals. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance mental well-being.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that multisensory entrainment, which includes both visual and sound stimulation, is safe and effective for reducing anxiety and stress. While sensitivity to light is a concern, most people tolerate it well.
Research indicates that vagus nerve stimulation, which helps control the body's stress response, is usually safe with only mild and temporary side effects. This technique calms the nervous system and reduces anxiety.
Transcranial electrical stimulation, which applies a gentle electrical current to the brain, has also been found to be safe. The most common side effects are mild, such as slight ear discomfort, with no reports of serious side effects.
Overall, these non-drug treatments have demonstrated good safety in previous research. They are generally well-tolerated and may offer promising options for those seeking alternative treatments for anxiety and related symptoms.12345Why are researchers excited about this trial?
Researchers are excited about these non-drug treatments for anxiety disorder because they offer unique approaches compared to traditional options like medication and talk therapy. These treatments focus on techniques such as multisensory state modulation, autonomic regulation, and cortical neuromodulation, providing alternative pathways to address anxiety. For instance, integrating AIP-informed psychotherapy with technologies like transcranial electrical stimulation or audiovisual entrainment could offer benefits without the side effects often associated with medication. Additionally, these approaches might work faster and more holistically by directly influencing physiological and neurophysiological functions, potentially leading to more personalized and effective anxiety management.
What evidence suggests that this trial's treatments could be effective for anxiety disorder?
Research has shown promising ways to treat anxiety without medication. In this trial, participants may receive transcranial electrical stimulation, which studies have found significantly reduces anxiety symptoms; one study reported a 70% decrease in patients. Another approach under study is vagus nerve stimulation, which calms the body's stress response and showed a 60-70% reduction in anxiety symptoms after a few months of treatment. These treatments affect signals in the brain and body, improving mood and reducing anxiety. Each offers a non-drug option for managing anxiety, potentially leading to quick and lasting relief.12467
Who Is on the Research Team?
Brian Pinkston, MD, MPH
Principal Investigator
Tactical Mind Research Coalition
Cheryl Lowry, MD, MPH
Principal Investigator
Tactical Mind Research Coalition
Are You a Good Fit for This Trial?
This trial is for adults experiencing ongoing mental health symptoms like anxiety, depression, trauma-related issues, sleep problems, attention difficulties (like ADHD), or substance use concerns. Participants are assigned treatments based on their specific symptoms and physiological measures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acute Treatment
Participants receive a personalized combination of noninvasive neuromodulation and AIP-informed integrative psychotherapy over approximately six structured sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points
What Are the Treatments Tested in This Trial?
Interventions
- AIP-Informed Integrative Psychotherapy
- Audiovisual Entrainment
- Breathwork-Based Auditory Driving Entropy Module (BADEM)
- Regulated Breathing and Autonomic Regulation
- Transcranial Electrical Stimulation
- Transcutaneous Auricular Vagus Nerve Stimulation
- Vibroacoustic Stimulation
Trial Overview
The study tests several non-drug therapies such as brain or nerve stimulation (using gentle electrical currents or vibrations), light and sound therapy, regulated breathing exercises, and integrative psychotherapy. Treatments are personalized to each participant's needs.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants assigned to Stack C receive a PRESET-Rx intervention emphasizing noninvasive cortical neuromodulation, combined with AIP-informed integrative psychotherapy. The intervention may include low-intensity transcranial electrical stimulation, delivered according to prespecified protocol criteria. Physiologic and neurophysiologic measures are collected during study sessions.
Participants assigned to Stack B receive a PRESET-Rx intervention emphasizing multisensory state modulation, combined with AIP-informed integrative psychotherapy. The intervention may include noninvasive visual, auditory, and vibroacoustic stimulation, delivered according to prespecified protocol criteria. Physiologic and neurophysiologic measures are collected during study sessions.
Participants assigned to Stack A receive a PRESET-Rx intervention emphasizing autonomic regulation, combined with AIP-informed integrative psychotherapy. The intervention may include noninvasive peripheral neuromodulation, regulated breathing, and related autonomic-regulation techniques, with treatment delivered according to prespecified protocol criteria. Physiologic and neurophysiologic measures are collected during study sessions.
Participants assigned to Stack D receive AIP-informed integrative psychotherapy without active neuromodulation or multisensory stimulation. Study assessments and physiologic/neurophysiologic measurements are performed according to the same study procedures used across intervention arms. Stack D serves as the active psychotherapy comparator.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tactical Mind Research Coalition, Inc.
Lead Sponsor
Citations
Vagus Nerve Stimulation - PMC - NIH
After implant, two weeks of post-surgery recovery without stimulation was followed by 10 weeks of active VNS. Approximately 30% responded and 15% achieved ...
Home-Based Transcutaneous Auricular Vagus Nerve ...
Previous taVNS studies have reported beneficial effects across neurological and psychiatric disorders including epilepsy, insomnia, and major ...
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feinstein.northwell.edu
feinstein.northwell.edu/news/insights/vagus-nerve-stimulation-and-mental-healthVagus nerve stimulation and mental health
Vagus nerve stimulation can ease inflammation in the body. Kevin Tracey, MD, explains the ways in which this can benefit our mental health.
The Effects of Vagus Nerve Stimulation on Stress, ...
Our findings demonstrate that 4 weeks of vagus nerve stimulation treatment significantly improved stress, cognitive anxiety, somatic anxiety, ...
Vagus Nerve Stimulation for Anxiety: 2026 Evidence Guide
VNS has been observed to reduce anxiety symptoms in 60-70% of patients within 3-6 months · Non-invasive options now available alongside ...
Vagus nerve stimulation (VNS): What you need to know
Activities that stimulate the vagus nerve may help slow your heart rate, lower blood pressure, reduce anxiety and improve digestion. Some ways ...
Safety of transcutaneous auricular vagus nerve stimulation ...
Although the general impression is that taVNS is a safe technique with only mild and transient adverse effects (AEs), human data on safety and ...
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